Early Development and Regulation of Diagnostic Testing for COVID-19: Frequently Asked Questions [Updated March 17, 2021]   [open pdf - 1005KB]

From the Document: "On December 31, 2019, the World Health Organization (WHO) was informed of a cluster of pneumonia cases in Wuhan City, Hubei Province of China. Illnesses have since been linked to a disease caused by a previously unidentified strain of coronavirus, designated Coronavirus Disease 2019, or COVID-19. Despite containment efforts in China, the United States, and elsewhere, by late February there were indications that the COVID-19 outbreak may have entered a new phase, with community spread occurring or suspected in several countries other than China, including in the United States. Since this time, the virus has spread widely, resulting in millions of cases and more than 500,000 deaths in the United States. Diagnostic testing is a critical part of the public health response to and clinical management of COVID-19. The earliest efforts in the United States to develop and disseminate a test for COVID-19 faced challenges. Manufacturing and quality issues with the nation's test--developed by the Centers for Disease Control and Prevention (CDC)--resulted in essentially all testing going through CDC's laboratory facility in Atlanta through early March 2020, despite distribution of test kits to state and local public health laboratories beginning in early February 2020. [...] In June 2020, HHS [Department of Health and Human Services] Office of the General Counsel released findings of an internal investigation into CDC's production of its test kit, finding generally that the test was likely contaminated, and that time pressure may have 'compromised sufficient QC/QA [quality control/quality assurance] to identify certain anomalies in data and realize the possibility of contamination before shipment.' In addition, the matter is currently under investigation by HHS Office of the Inspector General, with an audit underway to 'review CDC's process of producing and distributing the COVID-19 test kits.' This report is reportedly expected sometime in FY2021."

Report Number:
CRS Report for Congress, R46261
Public Domain
Retrieved From:
Congressional Research Service: https://crsreports.congress.gov/
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